Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Cephalon
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00373672
First received: September 6, 2006
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: armodafinil (Nuvigil)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • cognition [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
armodafinil (Nuvigil) 150 mg
Drug: armodafinil (Nuvigil)
armodafinil (Nuvigil)150 mg qd
Placebo Comparator: 2
identical in appearance to active comparator
Drug: placebo
identical in appearance to active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Men and women age 18-65 years
  • Patients with DSM-IV defined schizophrenia or schizoaffective disorder
  • Treated with any atypical antipsychotic for at least 2 months
  • Patients with documented weight gain > 7% with current antipsychotic medication
  • Able to provide written consent

Exclusion criteria

  • Women who are pregnant or nursing. Female participants must have a negative urine pregnancy test at screening.
  • DSM-IV defined substance or alcohol dependence within the 2 months preceding the start of the trial
  • Treatment with a monoamine oxidase inhibitor (e.g., tranylcypromine, phenelzine, isocarboxazid) within 2 weeks of starting the trial
  • Patients considered at high risk for suicide or violence
  • Patients with history of or symptoms on systems review consistent with clinically significant and currently relevant hematologic, renal, hepatic, gastrointestinal, endocrine, pulmonary, dermatologic, oncologic or neurologic (including seizures or epilepsy) disease
  • Patients with a history of or symptoms on systems review consistent with significant cardiovascular disease, bypass surgery, or concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure, angina pectoris, or recent (within last 6 months) myocardial infarction
  • Use of any investigational drug within 4 weeks before screening
  • History of hypersensitivity or other intolerable adverse effects to modafinil
  • Patients who experience severe sleep disturbances from modafinil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373672

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
Cephalon
Investigators
Principal Investigator: William V Bobo, M.D. Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00373672     History of Changes
Other Study ID Numbers: 060567
Study First Received: September 6, 2006
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
schizophrenia
cognition

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Armodafinil
Modafinil
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Wakefulness-Promoting Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on August 19, 2014